Senior CMC Project Manager
Company: Yoh, A Day & Zimmermann Company
Location: New Brunswick
Posted on: July 1, 2020
Are you actively seeking for a new Senior CMC Project Manager
role in New Brunswick, New Jersey? area or know someone that
I have a CONTRACT opportunity with an American pharmaceutical
company that manufactures prescription pharmaceuticals and
biologics in several therapeutic areas, including cancer, HIV/AIDS,
cardiovascular disease, diabetes, hepatitis, rheumatoid arthritis
and psychiatric disorders. If you meet the requirements, please
send me your updated resume to Kelly.Hua@Yoh.Com.
Position has the potential to be extended for 1 year.
Within the Product Development (PD) division, the Portfolio
Strategy and Integration (PSI) department brings together business
operations, project planning and execution, and portfolio
management with the vision of simplifying how Product Development
runs the business. A key goal of PSI is to drive the development
and execution of integrated CMC strategies via Chemistry
Manufacturing Control Teams (CMC) to enable R&D Development
Team objectives/deliverables. The Senior CMC Project Manager is
closely partnered with the CMC Leader to enable effective execution
of CMC strategy and plans.
The scope of responsibilities of the CMC Project Manager fall into
4 general categories which flex across all drug modalities, disease
areas and stages of development.
1) CMC Management, including meeting planning, facilitation and
2) CMC Project Timeline Management, including maintenance of
up-to-date MS project timelines and timeline scenario planning
3) Gaps Analysis and Risks Management
4) Allocation of drug substance and API materials for non-clinical
The PM is a leader, coordinator, and facilitator for the Portfolio
Strategy and Integration group, providing tactical direction,
managing teams, and providing tactical solutions that support the
overall program strategy developed by the CMC team.
Manages 4-6 CMCs (actual number determined by level of project
complexity and candidate experience) and drives execution of
program strategy by fostering communication and integration of all
functional area representatives on the CMC team.
Drives and manages all CMC meeting logistics including the creation
of clear and concise meeting minutes that will be shared as
appropriate to align all functional representatives of decisions
and actions agreed upon by the team.
Facilitates cross-functional sub-team meetings, as appropriate. Is
responsible for the development of a detailed CMC project plan that
is aligned with the overall program strategy.
Tracks all project milestones and clearly communicates status of
project through the use of established PSI tools.
Facilitate pertinent CMC scenario planning to address changing
Gather stakeholder input, evaluate, collate, manage and communicate
implications and adjustments to the overall plan Leverages
portfolio and program management tools to track program execution,
milestones, risks, and long range planning to ensure appropriate
communication to team members and management. Examples include the
following: PSI CMC Database OnePager Pro MS Project Server DOI Tool
Right First Time Scorecard Operational Risk Management.
The PM works collaboratively with the CMC Leaders and functional
leaders to track the critical operational aspects of the
program(s), including monitoring key deliverables, decision points,
demand planning, and critical path activities to drive delivery of
project objectives which roll up to the Product Development
Is responsible for contributing to the definition and execution of
risk management strategies, contingency planning, supporting the
development of a high performing team(s), and communication of the
solutions to management.
Partners with the CMC Leader to facilitate the management of risk
by scheduling meetings with the CMC team as appropriate.
The Senior CMC Project Manager is responsible for capturing all
gaps/risks into the appropriate PSI tools to enable effective
portfolio visuals of the gaps and risks.
Coordinates and ensure appropriate allocation of drug substance and
API materials for non-clinical use.
The Senior CMC Project Manager may: Lead certain cross-functional
sub-team meetings as may be needed Represent the CMC in certain
governance interactions, as appropriate Lead and/or participate in
Product Development portfolio level activities including business
process improvement initiatives and resource/budgeting activities,
Experience / Qualifications:
Bachelor's degree in engineering or relevant scientific discipline
with at least 5 years of relevant experience, Masters degree or PhD
with a minimum of 3-5 years of relevant experience.
Highly motivated self-starter that works well both in teams as well
Strong project management, business process management, and
Familiarity with end to end CMC drug development with an
understanding of critical milestones and typical bottlenecks
Strong organizational skills, ability to multi-task and work in a
dynamic, fast paced environment.
Demonstrated ability to accomplish results and meet deadlines and
Strong interpersonal and communications skills, both oral a
Demonstrated analytical and logic skills with a focus on fact-based
Demonstrated proficiency in MS Project, PowerPoint, Excel and
Demonstrated ability to build relationships, influence, negotiate,
and drive organizational engagement.
Experience developing and/or managing program management tools to
forecast budgets, timelines and resources preferred.
Opportunity is Calling,
What's In It For You?
We welcome you to be a part of one of the largest global staffing
companies to meet your career aspirations. Yoh's network of client
companies has been employing professionals like you for over 65
years in the U.S., UK and Canada. Join Yoh's extensive talent
community that will provide you with access to Yoh's vast network
of opportunities and gain access to this exclusive opportunity
available to you.
Medical, Dental & Vision Benefits
401K Retirement Saving Plan
Life & Disability Insurance
Direct Deposit & weekly ePayroll
Employee Discount Programs
Referral Bonus Programs
Yoh makes finding and applying for jobs simple. Partner with Yoh to
find the right opportunities across multiple industries in the US
and UK. Find out more
Yoh, a Day & Zimmermann company, is an Equal Opportunity
to contact us if you are an individual with a disability and
require accommodation in the application process.
Yoh Staffing.Category: Science, Keywords: Drug Development Project
Keywords: Yoh, A Day & Zimmermann Company, New Brunswick , Senior CMC Project Manager, Executive , New Brunswick, New Jersey
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